Study identification

PURI

https://redirect.ema.europa.eu/resource/36549

EU PAS number

EUPAS27594

Study ID

36549

Official title and acronym

A Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in European Patients in the Course of Routine Clinical Care (I5Q-MC-B002)

DARWIN EU® study

No

Study countries

France
Germany
Italy
Netherlands
Spain
Sweden
United Kingdom

Study description

To evaluate the utilisation and long-term safety of galcanezumab in Europe, in routine clinical practice.

Study status

Ongoing
Research institutions and networks

Institutions

Quantify Research
Sweden
First published:
14/02/2023
InstitutionOtherENCePP partner
University of Basel, in collaboration with the Boston Collaborative Drug Surveillance Program United Kingdom, University Institute for Primary Care Research Jordi Gol and University of Oxford Spain, Agenzia regionale di sanita della Toscana Italy, Quantify Research Sweden

Contact details

Eline Houben

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Study protocol
Initial protocol

I5Q-MC-B002 Galcanezumab_EU Long Term Safety_Drug Utilization_Protocol_amendment_Redacted

English (3.6 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)